Trial for Application of Laparoscopic Total Gastrectomy With Lymph Node Dissection for Gastric Cancer (KLASS-06)

NCT03385018 | Recruiting DMC

• 1 other identifier: 4-2017-0940
• Study Type: interventional
• Target: 772
• Locations: 1 country
• Sites: 1

Brief Summary

Although Laparoscopic gastrectomy for both early and locally advanced gastric cancer has gained popularity, the use of laparoscopic total gastrectomy for proximal advanced gastric cancer is still limited to some experienced surgeons, because of its technical difficulties in D2 lymph node dissection and anastomoses. Some retrospective and cohort studies regarding laparoscopic total gastrectomy with lymph node dissection suggested the likelihood of application of laparoscopic surgery for proximal gastric cancer. However, there has been no randomized clinical trial comparing results of laparoscopic total gastrectomy with D2 lymph node dissection with open conventional surgery. Therefore, we aimed to verify the efficacy of laparoscopic total gastrectomy with D2(D2-10) lymph node dissection, technical and oncologic safety compared with open surgery via multicenter randomized clinical trial.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• 3 year relapse-free survival

  Non-inferiority of 3 year relapse-free survival rate after laparoscopic radical total gastrectomy and lymphadenectomy for locally advanced gastric cancer comparing with open conventional surgery. The "event" of relapse-free survival is defined as "recurrence" after 4 weeks of operation. The "censoring" is defined as non-traceable patient who cannot be confirmed with recurrence or patient who are alive without recurrence until follow-up. The "relapse-free survival time" is defined as the time from surgery to "event" or "censoring".

  3 years after surgery

Secondary Outcomes (12)

• 3 year overall survival rate

  3 years after surgery

• 5 year relapse-free and overall survival

  5 years after surgery

• Morbidity (early period)

  from Operation day until POD 21

• Morbidity (late period)

  from POD (Post-Operative Day) 22 until 5 years after surgery

• Mortality

  at POD 30

Study Arms (2)

Laparoscopic group

EXPERIMENTAL

Arm Description: Laparoscopic radical total gastrectomy with D2 (or D2-#10) lymph node dissection

Procedure: Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by laparoscopic approach

Open group

ACTIVE COMPARATOR

Open radical total gastrectomy with D2 (or D2-#10) lymph node dissection

Procedure: Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by open conventional approach

Interventions

Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by laparoscopic approach PROCEDURE

* Total gastrectomy with D2(D2-10) lymph node dissection by laparoscopic approach * The number of trocars is 6 or less * Roux-en-Y esophagojejunostomy with any stapling method * Enough(negative) margin from tumor * LN station #1, 2, 3, 4d, 4sb, 5, 6, 7, 8a, 9, (10), 11p, 11d, 12a should be examined * Washing cytology * Frozen biopsy for surgical margin at surgeons discretion * Complete omentectomy for grossly serosa-involved tumor * Combined organ resection only in cholecystectomy and splenectomy * Indwelling nasogastric tube and drainage catheter at surgeons discretion * D2 lymphadenectomy should be performed : dissection of LN stations No.4d, 4sb, 4sa, 2, 10 (splenic hilar LN can be left according to the clinical stage), 6, 5, 12a, 8a, 9, 7, 1, 3, 11p, 11d with prevention of pancreatic injury during suprapancreatic dissection

Laparoscopic group

Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by open conventional approach PROCEDURE

* Total gastrectomy with D2(D2-10) lymph node dissection by open conventional approach * Roux-en-Y esophagojejunostomy with any stapling method * Enough(negative) margin from tumor * LN station #1, 2, 3, 4d, 4sb, 5, 6, 7, 8a, 9, (10), 11p, 11d, 12a should be examined * Washing cytology * Frozen biopsy for surgical margin at surgeons discretion * Complete omentectomy for grossly serosa-involved tumor * Indwelling nasogastric tube and drainage catheter at surgeons discretion * D2 lymphadenectomy should be performed : dissection of LN stations No.4d, 4sb, 4sa, 2, 10 (splenic hilar LN can be left according to the clinical stage), 6, 5, 12a, 8a, 9, 7, 1, 3, 11p, 11d with prevention of pancreatic injury during suprapancreatic dissection

Open group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are over 20 and below 80 years old
• Patients who have performance status of ECOG 0 or 1
• Patients with American Society of Anesthesiology score of class I to III
• Patients who are diagnosed with gastric adenocarcinoma not involving Z-line by endoscopy with biopsy
• Patients with tumors which can be curatively resected by total gastrectomy with lymph node dissection based on preoperative study
• Patients who have primary gastric carcinoma invaded into over muscle propria, and not into adjacent organ in preoperative studies (cT2 \~ cT4a)
• Patients who have no metastasis to lymph nodes or limited metastasis to perigastric lymph node metastasis in preoperative studies (cN0 \~ cN2)
• Patients who agree with participating in the clinical study with informed consents
• Patients who can be followed for at least 3 years after study enrollment

You may not qualify if:

• Patients who have possibility of distant metastasis in preoperative studies
• Patients who have history of gastric resection with any cause
• Patients who have complications (bleeding or obstruction) of gastric cancer
• Patients who are treated by chemo(radio)therapy or endoscopic submucosal dissection for gastric cancer
• Patients who are diagnosed and treated with other malignancies within 5 years
• Vulnerable patients
• Patients who participating or participated in other clinical trial within 6 months

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Surgery, Yonsei University College of Medicine, Seoul, Korea

Seoul, 120-752, South Korea

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Woo Jin Hyung, MD, PhD

CONTACT

+82-2-2228-2100; wjhyung@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2-arm randomized controlled study

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: December 28, 2017
• Study Start: April 5, 2018
• Primary Completion: December 31, 2022
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 19, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)